PhDRecalls & reported problems across all models
Merit Medical Systems, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one PhD model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 8 models of PhD by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Mar 10, 2021 and Aug 28, 2024 — classified as 1 injury, 3 malfunctions.
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
PhD recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 4, 2025Open, Classified
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
Z-0533-2026 · Root cause: Process change control · names 7 of these models · Recall details · FDA record ↗
Most reported PhD problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Air Embolism1
PhD models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PhD™ 00884450746745Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall2 reports
- PhD™ 00884450746714Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall1 report
- PhD™ TAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall0 reports
- PhD™ 00884450746721Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall0 reports
- PhD™ BAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall0 reports
- PhD™ 00884450746820Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall0 reports
- PhD™ TAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall0 reports
- PhD™ 00884450160503Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 report
Recent PhD adverse event reports
The 4 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2024
ELDERLY MALE WITH HISTORY OF CORONARY BYPASS GRAFT AND RECENT CHEST PAIN. PROCEDURE: LEFT HEART CATHETERIZATION. THE BACK END OF THE DEVICE IS SOLID- THERE IS NO OPENING FOR WIRE TO COME OUT. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS, PHD (PER SITE REPORTER), WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20085016 ↗MalfunctionJun 13, 2024
TRIED FLUSHING THE COPILOT, WOULD NOT FLUSH OUT THE BACK END OF THE COPILOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19527230 ↗MalfunctionMay 20, 2024
AT THE END OF PROCEDURE, TECH NOTICED AIR BUBBLES IN THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19351407 ↗InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS CORONARY INTERVENTION [PCI], AIR WAS ACCIDENTALLY INJECTED INTO THE PATIENT'S VASCULATURE SYSTEM. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED ARTERIAL ACCESS AND HAD NEGOTIATED THE PATIENT'S CORONARY ARTERY UNDER FLUOROSCOPY WITH A GUIDEWIRE AND AN INTERVENTIONAL GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS COMPLAINING ABOUT A HEMOSTASIS VALVE THAT WAS LEAKING FLUID AND CONTINUED TO USE THE HEMOSTASIS DEVICE. DURING THE PROCEDURE AIR WAS ACCIDENTALLY INJECTED INTO THE PATIENT'S CORONARY ARTERY, ECG CHANGES WERE NOTED AND CONFORMED THAT THE PATIENT WAS EXPERIENCING A MYOCARDIAL INFARCTION [MI] AND THE PROCEDURE WAS STOPPED TO OBSERVE VITAL SIGNS AND HEMODYNAMICS. ACLS AND BASIC LIFE SUPPORTING PROTOCOLS WERE ACTIVATED AND SUCCESSFULLY ADMINISTERED PER HOSPITAL POLICY. ADDITIONAL LIFESAVING INTERVENTIONS, TECHNIQUES, AND MEDICATIONS WERE REQUIRED.
Patient problems: Air Embolism
MAUDE report 11455227 ↗
Other Merit Medical Systems, Inc. products
- Aspira11 models · 36 reports · 10 recalls
- Impress145 models · 481 reports
- Monarch6 models · 37 reports · 7 recalls
- Bridge Prep Kit4 models · 6 reports · 3 recalls
- Prelude Roadster33 models · 1 reports · 3 recalls
- basixTOUCH6 models · 1 reports · 3 recalls
- basixCOMPAK34 models · 34 reports · 2 recalls
- Flex-Neck11 models · 21 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page